FDA Clears Wireless Electrocardiogram Device for Collecting Spirometry, ECG Data

An announcement was made by Clario, a company which is a major provider of clinical trial technologies and endpoint data solutions, that the US Food and Drug Administration (FDA) had provided 510(k) clearance for Clario’s ‘SpiroSphere’ integrated with the wireless COR-12 Electrocardiogram (ECG) device.¹

The company’s integration of both elements was designed with the goal of concurrent spirometry and ECG data gathering while utilizing a single site visit through Clario's SpiroSphere platform. This would allow for the collection of all ECG data into a single unified database.

"The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology," Tom Stuckey, senior vice president of Respiratory & Precision Motion at Clario, said in a statement. "This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety."

According to the company’s announcement about the FDA decision, the use of the single unified database was designed to help streamline the process of clinical trials. It would do so by removing the necessity of separate ECG devices or several different databases.

The SpiroSphere was first launched in the year 2018, the device serving as a lightweight and smart device for pulmonary function testing (PFT). However, the SpiroSphere’s design did not include ECG functionality in the beginning.

The newly-designed integration of the SpiroSphere ECG along with the wireless COR-12 ECG device may now allow for integrated respiratory and cardiac safety research, implementing a single device as well as a single database. The company notes that this will simplify the overall clinical study process.

The announcement highlights the integration and clearance by the FDA as being a technological breakthrough, adding that it allows for a more cost-effective solution to some of the aforementioned issues. Both efficiency and the experience of patients may be enhanced as a result.

References

1. ^{FDA clears Clario's SpiroSphere® with wireless ECG, streamlining data collection in clinical trials. Clario. June 13, 2024. https://clario.com/about/newsroom/fda-clears-clarios-spirosphere%EF%B8%8F-with-wireless-ecg-streamlining-data-collection-in-clinical-trials/. Date accessed: June 13, 2024.}